CTRI Number	CTRI/2017/09/009606 [Registered on: 04/09/2017] Trial Registered Retrospectively
Last Modified On:	08/09/2017
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study Modification(s)	Ayurveda
Study Design	Randomized, Parallel Group, Placebo Controlled Trial
Public Title of Study Modification(s)	Emblica officinalis effect on endothelial dysfunction and biomarkers in metabolic syndrome subjects.
Scientific Title of Study	Evaluation of the effect of a standardized aqueous extract of Emblica officinalis on endothelial dysfunction and biomarkers of oxidative stress in metabolic syndrome subjects.
Secondary IDs if Any	Secondary ID  Registry  EC/NIMS/011(d)/2012  Other
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  chavala Gayatri devi  Address  8-83-833/95,konduru residency, kamalapuri colony, Hyderabad dept. of clinical pharmacology and therapeutics, NIMS, Panjagutta, Hyderabad, 500082 Hyderabad ANDHRA PRADESH 500073 India  Phone  9291324797   Fax  09291324797   Email  gayatrichavala@gmail.com
Details Contact Person Scientific Query Modification(s)	Name  P Usha rani  Address  dept. of clinical pharmacology and therapeutics, NIMS, Panjagutta, Hyderabad Hyderabad ANDHRA PRADESH 500082 India  Phone  9849574143   Fax     Email  ushapingali@yahoo.com
Details Contact Person Public Query Modification(s)	Name  chavala Gayatri devi  Address  8-83-833/95,konduru residency, kamalapuri colony, Hyderabad Dept. of clinical pharmacology and therapeutics, NIMS, Panjagutta, Hyderabad, 500082 Hyderabad ANDHRA PRADESH 500073 India  Phone  9291324797   Fax  09291324797   Email  gayatrichavala@gmail.com
Source of Monetary or Material Support Modification(s)	Natreon Inc New Jersey USA
Primary Sponsor Modification(s)	Name  CGayatri Devi  Address  Dept. of Clinical Pharmacology and Therapeutics, NIMS, Hyderabad-500082  Type of Sponsor  Other [self funding]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  CGayatri Devi  Nizams Institute of Medical Sciences  Dept. of Clinical Pharmacology and Therapeutics, NIMS, Panjagutta, Hyderabad, 500082 Hyderabad   9291324797 9291324797 gayatrichavala@gmail.com
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  NIMS  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Metabolic syndrome
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Intervention  Emblica officinalis 250 mg capsules  Twice daily orally for 12 weeks  Intervention  Emblica officinalis 500 mg capsules  Twice daily orally for 12 weeks  Comparator Agent  Placebo capsules  Twice daily orally for 12 weeks
Inclusion Criteria	Age From  30.00 Year(s) Age To  68.00 Year(s) Gender  Both  Details  Patients were of either gender, aged 30-68 years, having endothelial dysfunction defined as ≤ 6% change in reflection index (RI) on post salbutamol challenge test and having metabolic syndrome.
ExclusionCriteria	Details  Patients with severe uncontrolled hypertension, uncontrolled hyperglycemia, impaired hepatic or renal function, cardiac arrhythmia, history of smoking, chronic alcoholism, malignancy or stroke, any other serious disease requiring active treatment and treatment with any other herbal supplements
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	Case Record Numbers
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome Modification(s)	Outcome  TimePoints  change in endothelial dysfunction as assessed by more than 6% change in reflection index  change in endothelial dysfunction as assessed by more than 6% change in reflection index after 12 weeks of treatment
Secondary Outcome	Outcome  TimePoints  change in oxidative stress markers, serum levels of NO, GSH, MDA and hsCRP.safety and tolerability assessment of the test medications   12 weeks of treatment
Target Sample Size Modification(s)	Total Sample Size="59" Sample Size from India="59"
Phase of Trial	N/A
Date of First Enrollment (India) Modification(s)	21/05/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	not yet published
Brief Summary Modification(s)	Emblica officinalis is useful in the prevention of diabetes mellitus and believed to increase defense against various other diseases. The objective of the study is to evaluate the effect of standardized aqueous extract of fruits of Emblica officinalis 250mg, 500mg, and placebo on endothelial dysfunction, biomarkers of oxidative stress and inflammation in metabolic syndrome subjects. Fifty-nine eligible subjects having endothelial dysfunction and metabolic syndrome were randomized to receive either Embilica officinalis 250mg, 500mg or Placebo twice daily for 12 weeks. The primary efficacy criterion was a change in endothelial dysfunction assessed by salbutamol challenge test at baseline and end of the treatment.  Secondary efficacy parameters were a change in oxidative stress markers, serum levels of NO, GSH, MDA and inflammatory marker hsCRP estimated using standard techniques at baseline and end of the treatment.  Lipid profile and safety laboratory parameters were also measured at the baseline and the end of therapy. Both  Emblica officinalis 250mg and 500mg showed a significant reduction in reflection index compared to baseline and placebo (p<0.001). Both doses showed a significant increase in NO and MDA levels and decreased in GSH, hsCRP levels compared to baseline and placebo (p<0.001). Further, both active therapies significantly improved the lipid profile levels compared to baseline and placebo (p<0.05).The present study concluded that treatment with Emblica officinalis 250mg and 500mg showed significant improvement in endothelial dysfunction, biomarkers of oxidative stress and inflammation in metabolic syndrome subjects.